ATELVIA

AbsorptionThe mean absolute oral bioavailability of the 30 mg risedronate sodium immediate-release tablet taken 4 hours prior to a meal is 0.63% (90% confidence interval [CI]: 0.54% to 0.75%) and is similar to an oral solution. The time to peak concentration (T max ) for Atelvia tablet is approximately 3 hours when administered in the morning 4 hours prior to a meal. Food Effect In a crossover pharmacokinetic study, the bioavailability of Atelvia 35 mg delayed-release tablets decreased by appro...

Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Once-a-Week Dosing with Atelvia ( risedronate sodium) delayed-release tablets The safety of Atelvia 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing Atelvia 35 mg once-a-week to risedronate sodium im...

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] Mineral Metabolism [see Warnings and Precautions (5.3) ] Jaw Osteonecrosis [see Warnings and Precautions (5.4) ] Musculoskeletal Pain [see Warnings and Precautions (5.5) ] Atypical Fractures Including Femoral Fractures [see Warnings an...

Atelvia is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.2) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2) , Warnings and Precautions (5.2) ] Hypocalcemia [see Warnings and Precautions (5.3) ] Known hypersensi...

Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with Atelvia ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the J aw has been reported ( 5.4 ) Severe B one, J oint, M uscle P ain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) At...

7 DRUG INTERACTIONS Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium supplements, antacids, proton pump inhibitors (PPIs), H 2 blockers, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of Atelvia ( 7.1 , 7.2 ) 7.1 Calcium Supplements/Antacids When Atelvia ...